Sugemalimab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | PD-L1, (CD274) |
| Clinical data | |
| Trade names | Cejemly, Eqjubi |
| Other names | CS-1001, WBP-315 |
| Routes of administration | Intravenous |
| Drug class | Antineoplastic |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| UNII | |
| KEGG | |
Sugemalimab, sold under the brand name Cejemly, is a monoclonal antibody used for the treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy.[1] It is an antineoplastic monoclonal antibody that potentiates T-cell responses, including anti-tumor responses, through blockade of PD-1 binding to PD-L1 ligands.[1]
It is a fully human monoclonal antibody directed against the immunosuppressive ligand, programmed cell death-1 ligand 1 (PD-L1; cluster of differentiation 274; CD274), with potential immune checkpoint inhibitory and antineoplastic activities.[3] Upon administration, sugemalimab specifically targets and binds to PD-L1, blocking its binding to and activation of its receptor, programmed cell death 1 (PD-1).[3] This reverses T-cell inactivation caused by PD-1/PD-L1 signaling and enhances the cytotoxic T-lymphocyte (CTL)-mediated anti-tumor immune response against PD-L1-expressing tumor cells.[3] PD-L1 is overexpressed by many human cancer cell types.[3] PD-L1 binding to PD-1 on T-cells suppresses the immune system and results in immune evasion.[3] PD-1, a transmembrane protein belonging to the immunoglobulin superfamily expressed on activated T-cells, is a negative regulator of the immune system that limits the expansion and survival of CD8-positive T-cells.[3] Anti-PD-L1 monoclonal antibody CS1001 mirrors natural immunoglobulin G4 (IgG4), potentially reducing immunogenicity and other toxicities.[3]
Society and culture
[edit]Legal status
[edit]In May 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cejemly, intended for the first-line treatment of metastatic non-small cell lung cancer in combination with chemotherapy.[1][4] The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.[1] Sugemalimab was approved for medical use in the European Union in July 2024.[1][2]
In October 2024, the UK`S Medicines and Healthcare products Regulatory Agency approved sugemalimab as part of a first-line combination treatment for lung cancer. It would be used alongside platinum-based chemotherapy to treat adults with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. The approval was granted to CStone Pharmaceuticalsn under trade name Eqjubi.[5]
Approval was based on the findings from the multicenter, randomized, double-blind phase 3 GEMSTONE-302 trial (NCT03789604).[6][7]
Names
[edit]Sugemalimab is the international nonproprietary name.[8]
References
[edit]- ^ a b c d e f "Cejemly EPAR". European Medicines Agency. 30 May 2024. Retrieved 1 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ a b "Cejemly PI". Union Register of medicinal products. 25 July 2024. Retrieved 28 July 2024.
- ^ a b c d e f g "Sugemalimab (Code C154550)". NCI Thesaurus. 29 April 2024. Retrieved 1 June 2024.
This article incorporates text from this source, which is in the public domain.
- ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024". European Medicines Agency (Press release). 31 May 2024. Retrieved 13 June 2024.
- ^ "MHRA approves CStone Pharmaceuticals' sugemalimab to treat lung cancer in adults - PMLiVE". pmlive.com. 4 November 2024. Retrieved 5 November 2024.
- ^ "A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer". clinicaltrials.gov. Retrieved 5 November 2024.
- ^ Zhou C, Wang Z, Sun M, Cao L, Ma Z, Wu R, et al. (22 June 2023). "Interim survival analysis of the randomized phase III GEMSTONE-302 trial: sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC". Nature Cancer. 4 (6): 860–871. doi:10.1038/s43018-023-00578-z. ISSN 2662-1347.
- ^ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
